Hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. With pathological diagnosis or diagnostic standards in line with the AASLD (the American association for the study of liver diseases) the prescribed standards for clinical diagnosis of Hepatocellular carcinoma; 2. A diagnosis of Hepatocellular carcinoma (not surgically removable), and accept the 2-3 cycles TACE therapy or postoperative recurrence of inoperable liver and accept 2-3 cycles TACE treatment; 3. BCLC tumour stage belongs to the mid-(B period), late (C phase); 4. liver function Child-Pugh score less than or equal to 7 points; 5. Easten Cooperative Oncology Group(ECOG) performance status 0-2; 6. Age >=18 years; 7. At least one measurable lesion by CT or MRI; 8. Life expectancy >=6 months; 9. Signed informed consent document; 10. Ability to comply with requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with radiotherapy, chemotherapy, immunotherapy or targeted therapy; 2. History of organ allograft, autologous stem cell transplantation, or allogeneic stm cell transplantation; 3. Use of immunosuppressant within one month of trial entry, including corticosteroids >=1 months of continuous use those; 4. Previous exposure to any investigational treatment within 30 days before the first dose of study treatment; 5. Known and declared history of Acquired immunodeficiency syndrome (AIDS related diseases) or HIV infection need antiretroviral; 6. Other serious diseases, including epilepsy; 7. Pregnant or Lactating females; 8. Extrahepatic metastasis: There portal vein, inferior vena cava, hepatic vein tumor thrombus; abdominal lymph node metastasis; 9. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.; 10. Active infection; 11. A history of severe lung or heart disease; renal abnormalities, plasma creatinine exceeds 1.5 times the upper limit of normal; 12. Upper gastrointestinal bleeding had occurred caused by cirrhosis of the liver; 13. Legal incapacity or limited legal capacity; 14. Has a physical or mental illness, and by investigator believe can not be completely or fully understand the complications that may exist in this study; 15. History of other malignancy, other than curatively treated carcinoma in situ of the cervix, and curatively treated cutaneous basal cell carcinoma; 16. Any severe acute or chronic disease that make patient can't participate or impact the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free surival;Safty of immunotherapy;Overall Survival;T/Treg cell;cytokines (IFN-beta, IL-10); | — |
Countries
China